The Post-Vitrectomy Lenstatin™ Study
| Status: | Completed |
|---|---|
| Conditions: | Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | June 2014 |
| End Date: | December 2015 |
The Post-Vitrectomy Lenstatin Study: A Prospective Randomized Double Blind Human Clinical Trial Testing the Efficacy of Lenstatin in Inhibiting Cataract Formation and Progression After Pars Plana Vitrectomy
To determine the efficacy of Lenstatin™, an over-the-counter nutritional supplement, in
inhibiting the progression of nuclear cataract in eyes after pars plana vitrectomy.
inhibiting the progression of nuclear cataract in eyes after pars plana vitrectomy.
BACKGROUND AND RATIONALE
There are conflicting reports on the effectiveness of nutritional antioxidants in preventing
or slowing the growth of age related cataracts, despite extensive laboratory evidence
suggesting that oxidative damage to lens epithelial cells is a common underlying etiologic
factor in cataractogenesis. One reported review of nine clinical trials involving over
117,000 patients suggested that beta-carotene, Vitamin E, and Vitamin C had no effect in
preventing or slowing the progression of age-related cataract. Conversely, a randomized
trial of over 14,000 US male physicians indicated that long-term daily multivitamin use
modestly and significantly decreased the risk of cataract.
Cataract formation following pars plana vitrectomy is a well recognized post-operative
complication of the procedure, with the reported incidence of clinically significant
cataract development as high as 80% within 2 years after pars plana vitrectomy.
INVESTIGATIONAL AGENT
Lenstatin™ is a proprietary formulated nutritional supplement containing 11 micronutrients
and anti-oxidants intended to be taken for the nutritional support of the human crystalline
lens.
INTERVENTION
Participants will be randomized to treatment with Lenstatin or Placebo for (6) months
following pars plana vitrectomy.
STUDY METHODS
Participants will have baseline nuclear density (cataract) measurements using the Pentacam
Nucleus Staging (PNS) program. The Pentacam Scheimpflug imaging system is a non-contact and
non-invasive anterior segment imaging device which has been shown to provide an immediate,
quantitative, examiner-independent measurement of lens density which correlates with the
LOCS III cataract grade. Serial Pentacam nuclear density measurements will be taken on each
participant at (1) month intervals for (6) months.
There are conflicting reports on the effectiveness of nutritional antioxidants in preventing
or slowing the growth of age related cataracts, despite extensive laboratory evidence
suggesting that oxidative damage to lens epithelial cells is a common underlying etiologic
factor in cataractogenesis. One reported review of nine clinical trials involving over
117,000 patients suggested that beta-carotene, Vitamin E, and Vitamin C had no effect in
preventing or slowing the progression of age-related cataract. Conversely, a randomized
trial of over 14,000 US male physicians indicated that long-term daily multivitamin use
modestly and significantly decreased the risk of cataract.
Cataract formation following pars plana vitrectomy is a well recognized post-operative
complication of the procedure, with the reported incidence of clinically significant
cataract development as high as 80% within 2 years after pars plana vitrectomy.
INVESTIGATIONAL AGENT
Lenstatin™ is a proprietary formulated nutritional supplement containing 11 micronutrients
and anti-oxidants intended to be taken for the nutritional support of the human crystalline
lens.
INTERVENTION
Participants will be randomized to treatment with Lenstatin or Placebo for (6) months
following pars plana vitrectomy.
STUDY METHODS
Participants will have baseline nuclear density (cataract) measurements using the Pentacam
Nucleus Staging (PNS) program. The Pentacam Scheimpflug imaging system is a non-contact and
non-invasive anterior segment imaging device which has been shown to provide an immediate,
quantitative, examiner-independent measurement of lens density which correlates with the
LOCS III cataract grade. Serial Pentacam nuclear density measurements will be taken on each
participant at (1) month intervals for (6) months.
Inclusion Criteria:
- Adults over the age of 18
- Post pars plana vitrectomy surgery
Exclusion Criteria:
- Pediatric patients under the age of 18
- Pregnant women
- Hypersensitivity to any of the ingredients in Lenstatin
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